| 01.09.2021 | 301-213/2021 | Datex-Ohmeda, Inc., ZDA | Flow Sensors used in the GEHC anesthesia machines |
| 03.09.2021 | 301-214/2021 | Abbott Molecular, Inc., ZDA |
Alinity m SARS-CoV-2 Amplification Reagent Kit Kit (List Numbers 09N78-090 and 09N78-091)
Alinity m Resp-4-Plex Amplification Reagent Kit ( List Number 09N79-090)
Alinity m SARS-CoV-2 Amplification Reagent Kit Emergency Use Authorization (EUA), List Number 09N78-095 (out of EEA only)
Alinity m Resp-4-Plex Amplification Reagent Kit Emergency Use Authorization (EUA), List Number 09N79-096 (out of EEA only) |
| 06.09.2021 | 301-215/2021 | Beckman Coulter, Inc., ZDA | Access hsTnI Reagent (High Sensitivity Troponin I) |
| 11.09.2021 | 301-216/2021 | Datascope Corp. Getinge, ZDA | Cardiosave Intra-Aortic Balloon Pumps |
| 13.09.2021 | 301-217/2021 | ZOLL Circulation, Inc, ZDA | COOL LINE, ICY, Quattro and Solex IVTM Catheters |
| 15.09.2021 | 301-218/2021 | Elekta, Ltd, VB | Linear Accelerator |
| 16.09.2021 | 301-219/2021 | William Cook Europe ApS, DK | Inferior Vena Cava (IVC) Filter |
| 16.09.2021 | 301-220/2021 | Medtronic Inc., ZDA | Activa Clinician Programmer Application |
| 17.09.2021 | 301-221/2021 | PAUL HARTMANN AG, DE | Zetuvit® E |
| 22.09.2021 | 301-223/2021 | Limacorporate SPA, IT | BONE SCREW Ø6,5 H.20MM – H.25MM TI6AL4V |
| 27.09.2021 | 301-224/2021 | Carl Zeiss Meditec AG, DE | AT LISA tri 839MP |
| 28.09.2021 | 301-225/2021 | RaySearch Laboratories AB (Publ), SE | Ray Station |
| 29.09.2021 | 301-158/2019 | Siemens Healthcare Diagnostics, Inc., US | Stratus® CS Acute Care™ cTNI TestPak
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